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A Study of IO103 in Montanide Adjuvant for Basal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03714529
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : November 26, 2018
University of Copenhagen
Information provided by (Responsible Party):
jeanette kaae, Herlev and Gentofte Hospital

Brief Summary:
A single center, open-label, phase IIa, single arm, window of opportunity trial with IO103 and Montanide adjuvant in patients with surgically resectable BCC.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Biological: PD-L1 Phase 2

Detailed Description:

10 patients with BCC will be vaccinated with a peptide derived from the immune checkpoint molecule PD-L1. Patients will be vaccinated once every 2 weeks (Q2W) for 10 weeks and then evaluated for a clinical response.

Patients with clinical response to vaccination will continue with one vaccination once every 4 weeks (Q4W) for 12 weeks and thus receive 9 vaccinations in total over the course of 22 weeks.

Patients with no effect of treatment after 6 vaccinations will be treated with standard of care (SOC).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIa Trial With PD-L1 IO103 Vaccination With Montanide in Patients With Basal Cell Carcinoma
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : July 15, 2019

Arm Intervention/treatment
Experimental: Treatment arm

The vaccine consists of 500µl of 100µg PD-L1 peptide, dissolved in DMSO and PBS reconstituted with 500 µl Montanide ISA-51.

Patients will be vaccinated Q2W for 10 weeks, and a further 12 weeks if a clinical response is measured.

Biological: PD-L1
IO103 is a anti-cancer therapy consisting of a synthetic PD-L1-derived peptide.
Other Name: IO103

Primary Outcome Measures :
  1. Disease control rate [ Time Frame: After 6 vaccinations (10 weeks) ]
    Defined as a reduction in the largest diameter of target BCC measured in millimetres (mm) as well as clinical photographs

  2. Immune responses [ Time Frame: After 6 vaccinations (10 weeks) ]
    Blood samples and Tumor biopsy samples (3-4 mm in size) for bioanalysis of programmed death ligand 1 (PD-L1) specific responses

Secondary Outcome Measures :
  1. Immune responses in skin [ Time Frame: After 6 vaccinations (10 weeks) ]
    Skin-infiltrating lymphocytes (SKILs) will be grown to test for PD-L peptide specificity

  2. Incidence of treatment emergent adverse events (safety and tolerability) [ Time Frame: After 6 vaccinations (10 weeks) ]
    Events will be recorded and graded using CTCAE version 4.03

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 18
  2. At least 1 histological verified superficial or nodular basal cell carcinoma on the body or limbs of bigger than 14 mm in the longest diameter
  3. Willing to provide three 4 mm biopsies from the lesion/lesions
  4. Not previously treated with a hedgehog pathway inhibitor
  5. For women of childbearing potential: Agreement to use contraceptive methods with a failure rate of < 1 % per year during the treatment period and for at least 150 days after the treatment. Safe contraceptive methods for women are birth control pills, intrauterine device, contraceptive injection, contraceptive implant, contraceptive patch or contraceptive vaginal ring.
  6. For men: Agreement to use contraceptive measures and agreement to refrain from donating sperm
  7. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial in accordance with ICH-GCP and local legislation prior to admission to the trial
  8. Sufficient bone marrow function, i.e.

    1. Leucocytes ≥ 1,5 x 109
    2. Granulocytes ≥ 1,0 x 109
    3. Thrombocytes ≥ 20 x 109

2. Creatinine < 2.5 upper normal limit, i.e. < 300 μmol/l 3. Sufficient liver function, i.e.

  1. ALAT < 2.5 upper normal limit, i.e. ALAT <112 U/l
  2. Bilirubin < 30 U/l

Exclusion Criteria:

  1. The patient has a history of life-threatening or severe immune related adverse events on treatment with another immunotherapy and is considered to be at risk of not recovering
  2. The patient has a history of severe clinical autoimmune disease
  3. The patient has a history of pneumonitis, organ transplant, human immunodeficiency virus positive, active hepatitis B or hepatitis C
  4. The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders)
  5. The patient is pregnant or breastfeeding
  6. The patient has an active infection requiring systemic therapy
  7. The patient has received a live virus vaccine within 30 days of planned start of therapy
  8. Known side effects to Montanide ISA-51
  9. Significant medical disorder according to investigator; e.g. severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus
  10. Concurrent treatment with other experimental drugs
  11. Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
  12. Severe allergy or anaphylactic reactions earlier in life.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03714529

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Contact: Jeanette Kaae, Dr +45 38 67 31 40
Contact: Lone Skov, Prof +45 38 67 32 04

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Herlev and Gentofte Hospital Recruiting
Hellerup, Hovedstaden, Denmark, 2900
Contact: Jeanette Kaae, MD    +45 38 67 38 67   
Contact: Lone Skov, Prof    +45 38 67 38 67   
Sponsors and Collaborators
Herlev and Gentofte Hospital
University of Copenhagen
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Study Director: Inge Marie Svane, Prof Herlev and Gentofte Hospital
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Responsible Party: jeanette kaae, MD PhD, Herlev and Gentofte Hospital Identifier: NCT03714529    
Other Study ID Numbers: BCC1810
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell